Kornimate/medical-research-clean huggingface dataset:
measurable residual disease detection using tumor-informed ctdna surveillance after curative-intent treatment in hpv-independent squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.

this is a two-arm, prospective, observational study of patients with human papillomavirus (hpv)-independent head and neck squamous cell carcinoma (hnscc) who are receiving curative-intent treatment. arm 1 will consist of patients who undergo surgery. arm 2 will consist of patients who undergo chemoradiotherapy. the study will test the following hypotheses: 1. that applying a tumor-informed minimal residual disease (mrd) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are mrd positive) and patients who will remain disease-free (those who are mrd negative). the hypothesis is that patients who have detectable ctdna following treatment-mrd positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctdna-mrd negative patients-will remain disease free at 2 years. 2. that measuring mrd after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months. the primary outcome is 2-year dfs in patients with detectable vs no detectable ctdna two weeks after treatment completion. the study will accrue 75 patients, who will be followed for a minimum of 2 years. subjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (haystack mrd™)

Eligibility criteria:
inclusion criteria: * newly diagnosed ajcc 8th edition stage iii-ivb mucosal scc of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx. * available tissue for tumor-informed ctdna panel creation. * definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at massachusetts eye and ear institute (meei) or within the massachusetts general hospital (mgh) cancer center (including but not limited to the boston, danvers, and newton-wellesley locations). exclusion criteria: * patients \<18 years of age * patients receiving non-standard of care therapy as determined by the clinical investigator * participants who have undergone prior surgical resection, excisional biopsy, radiation, and/or chemotherapy for the treatment of hnscc. prior incisional biopsies are permitted. discrepant cases will be reviewed by study pi. * participants who are receiving any investigational agents at the time of enrollment. * participants with ajcc stage ivc hnscc, which includes patients with biopsy-confirmed distant metastatic hnscc, including but not limited to metastatic spread to the lungs, bones, or liver. * active non-hnscc malignancy. * active pregnancy during treatment.
survey about diet in chronic inflammatory rheumatic diseases

Conditions: Rheumatic Disease; Rheumatic Disorder; Inflammatory Rheumatism; Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis; Spondylitis, Ankylosing; Diet Habit; Feeding Behavior

Summary: a french survey on patients' practices, knowledge and beliefs about diet in chronic inflammatory rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, spondylarthritis) use of a questionnaire about what patients have heard concerning diet and rheumatism, what kind of diet they tried eventually and how it affected their health and disease


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis, psoriatic arthritis) according to the diagnostic criteria commonly admitted * patient followed in the rheumatology department of the university hospital of poitiers (france) * free patient, without guardianship or tutelage or subordination * patient not opposing to participate in the study exclusion criteria: * patient withdrawing consent * patient who does not meet criteria for chronic inflammatory disease (rheumatoid arthritis, spondylarthritis, psoriatic arthritis) according to the diagnostic criteria commonly admitted after examination of medical record

Keywords: survey questionnaire diet inflammatory rheumatism
comparative study of the hypoxia measured in faza and f-miso pet/ct scan in patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of the study is to compare the intratumoral biodistribution of faza and f-miso in patients with non-small cell lung cancer and correlate the results of pet scans with immunohistochemistry.

the aim of the study is to compare the biodistribution of the two tracers specific for hypoxia in patients with non-small cell lung cancer. two pet scans will be performed with faza and f-miso tracers. the time between these twi pet scans will be 24 hours. another 24 hours after the late pet scan, the surgery will be done and a piece of tumor will be collected. piece of tumor will be analysed by immunohistochemistry for hypoxia markers. the results of immunohistochemistry will be correlated with the biodistribution of the two tracers.

Eligibility criteria:
inclusion criteria: * male or female * more than 18 years old * patient with non-small cell lung cancer (histologically proved) * ps inferior or equal to 1 (good general state) * patient must have surgery for their non-small cell lung cancer * stage of tumor superior or equal to 2a without metastasis * tumoral fixation with 18-fdg-pet superior to mediastinal background noise * written inform consent exclusion criteria: * histology other than primitive non-small cell lung cancer * in situ form at the histological study * patient without evaluable target * no fixation on the pretherapeutic fdg-pet scan * ps superior or equal to 2 * neoplastic disease (less than 2 years or progressive) * pregnant woman or child-bearing * patient under guardianship or curators

Keywords: pet scan faza f-miso hypoxia lung cancer
study of nktr 255 in combination with cetuximab in solid tumors

Conditions: Head and Neck Squamous Cell Carcinoma; Colorectal Cancer

Summary: this is a phase 1b/2, open-label multicenter study evaluating nktr-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (hnscc) and colorectal carcinoma (crc).

nktr-255 is a cytokine that is designed to regulate t and natural killer cell activation, proliferation and promote their anti-tumor effects. in the dose escalation (phase 1/b) phase patients with hnscc or crc will be treated with ascending doses of nktr-255 in combination with cetuximab, until the maximum tolerated dose (mtd) and/or the recommended phase 2 dose (rp2d) is reached.

Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of a locally advanced or metastatic hnscc or crc. * life expectancy \> 12 weeks as determined by the investigator. * eastern cooperative oncology group (ecog) performance status 0 or 1. * measurable disease per recist 1.1. hnscc: * progression on any first or second line platinum-based chemotherapy and/or anti-pd-1 or programmed death-ligand 1 antibody. crc: * patients must have received or were intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease. key exclusion criteria: * use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s) * prior surgery or radiotherapy within 14 days of initiating study drug(s) * evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis; active infection requiring systemic therapy within 7 days prior to dosing * patients who have been previously treated with il-2 or il-15 * known grade 3 or 4 hypersensitivity reaction to cetuximab, history of allergy to red meat or tick bites, or history of positive test results for immunoglobulin e antibodies against cetuximab * patients who have an active, known, or suspected autoimmune disease note: other protocol defined inclusion/exclusion criteria may apply

Keywords: hnscc head and neck squamous cell carcinoma crc colorectal cancer nktr-255 cetuximab erbitux®
effect of antibiotics on gut microbiome and plasma metabolome

Conditions: Microbial Colonization

Summary: in recent years it has been observed that the gut microbiome can produce metabolites into systemic circulation and thus have important health effects even outside the gastrointestinal system. these metabolites may play a role in the pathogenesis of common public health problems such as diabetes, obesity and cardiovascular disorders. modern techniques of mass spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now enable detailed examination of these processes. using samples from the finrisk 2002 cohort, collected by the national institute for health and welfare, we are currently determining the gut microbiome and plasma metabolome from \> 7000 participants with 15 years of follow-up for various health outcomes. this is one of the largest materials of its kind world-wide. the design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in the composition of plasma metabolome. to enable conclusions which go beyond statistical associations, we now propose an extension to the finrisk 2002 study, where we alter the gut bacteriome with a short course of antibiotics and then examine whether a change in plasma metabolomics profile will follow. at the same time the trial will give important novel information about the effects of commonly used antibiotics on gut bacteriome and on general health.


Eligibility criteria:
inclusion criteria: * prior participation in the finrisk 2002 survey and current residence in helsinki metropolitan area. * age range 40-74 years among men and 50-74 years among women. exclusion criteria: * known allergy to any antibiotic * a course of antibiotic during the past year * acute infection * any major illness (history of myocardial infarction, stroke, diabetes, liver or kidney disease, cancer, psychiatric disease). uncomplicated hypertension is allowed. likewise, statin treatment and women's hormone replacement therapy are allowed.

Keywords: microbiota metabolize
evaluating the effect of injectable platelet-rich fibrin on accelerating orthodontic tooth movement

Conditions: Tooth Mobility; Injectable Platelet-rich Fibrin

Summary: one of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. the previous studies evaluating platelet-rich fibrin (prf) and orthodontic tooth movement (otm) are limited, which makes the results difficult to generalize.

one of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. the previous studies evaluating platelet-rich fibrin (prf) and orthodontic tooth movement (otm) are limited, which makes the results difficult to generalize. to this end, we set up this randomized experiment to evaluate the effect of the injectable form of prf (i-prf) on otm, using nonadditive containing i-prf, which has higher levels of regenerative cells and growth factors compared with other prf types because of the use of low centrifugation spee. accordingly, we aimed to evaluate the effect of i-prf on the rate of maxillary incisors leveling during comprehensive orthodontic treatment.

Eligibility criteria:
inclusion criteria: * the patient's age (18-26). severe or very severe irregularity of the upper incisors greater than (7 mm) according to little's index, so it is recommended to extract the upper first premolar. * class i or class ii malocclusion, first model according to angle, with skeletal class i or ii and a normal or mild vertical growth pattern. * all permanent upper teeth, up to the first molar, are present, with the possibility of attaching brackets to all teeth in a correct position. * the patient has good oral health. exclusion criteria: * • the presence of any systemic disease that affects orthodontic dental movement. * severe malalignment of one of the teeth (palatal quadrant, ectopic canine, ectopic premolar). * the patient has undergone previous orthodontic treatment. * the patient is subject to any drug treatment that may affect orthodontic dental movement (cortisone, non-steroidal anti-inflammatory drugs). * the patient has poor oral health. * commitment to periodic follow-up appointments.
pulmonary rehabilitation for idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to determine the effects of pulmonary rehabilitation (pr) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with idiopathic pulmonary fibrosis (ipf). pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (copd). we believe that pulmonary rehabilitation will benefit patients with ipf as well.

the goals of this project are to assess the effect of pr on a number of important outcomes in patients with ipf. once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient pr program (at national jewish medical and research center or other pr programs). subjects will complete the same battery of questionnaires and tests immediately after completion of the pr program and again six months later.

Eligibility criteria:
inclusion criteria: * age 40 years or older * diagnosis of ipf according to american thoracic society criteria exclusion criteria: * patients who have completed a pr program within the last two years * patients with unstable medical conditions that would make pr unsafe

Keywords: pulmonary fibrosis pulmonary rehabilitation dyspnea quality of life
a study of the safety and efficacy of a new treatment for non-infectious anterior uveitis

Conditions: Anterior Uveitis

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious anterior uveitis.


Eligibility criteria:
inclusion criteria: * 18 years or older with a diagnosis of non-infectious anterior uveitis in at least one eye exclusion criteria: * uncontrolled systemic disease * any active ocular infections
total knee arthroplasty: fast track protocol is the future?

Conditions: Osteoarthritis, Knee; Arthropathy of Knee

Summary: fast-track total knee arthroplasty (tka) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. the aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

the aim of this protocol is to compare standard care and fast track total knee arthroplasties. the fast track care consists of: * preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients * antalgic protocol administered only orally * early rehabilitation care. the day of the surgical operation, the physiotherapist helps the patient reach the upright position. the standard care consists of usual antalgic and physiotherapy post-operative care: * antalgic protocol consist in intravenous drugs * the first physiotherapy session is the day after surgery.

Eligibility criteria:
inclusion criteria: * patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty * bmi \< 32 * time up ang go test \</= 12 seconds * american society of anesthesiologists physical status classification system (asa) \</= 2 * preoperative hemoglobin (hb) \>13 g/dl * patients eligible for spinal anesthesia * presence of a care-giver exclusion criteria: * psychiatric diseases * preoperative use of crutches * asa \> 3 * preoperative hb \< 13 g/dl

Keywords: fast track care total knee arthroplasty
study of arb-001467 in subjects with chronic hbv infection receiving nucleos(t)ide analogue therapy

Conditions: Hepatitis B, Chronic

Summary: the study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (pk) following multiple doses of intravenous arb-001467

approximately 24 subjects will be enrolled in three cohorts: two cohorts of hbeag-negative subjects and one cohort of hbeag-positive subjects and 12 hbeag-negative subjects will be enrolled in cohort 4. all subjects will be non-cirrhotic, with chronic hepatitis b virus (hbv) infection, and will have been receiving nucleos(t)ide-analogue (na) therapy with entecavir or tenofovir for at least 12 months.

Eligibility criteria:
key inclusion criteria: * documented chronic hbv infection for ≥12 months prior to screening visit. * quantitative hbsag ≥1000 iu/ml at the screening visit. * subjects currently receiving entecavir and/or tenofovir for ≥12 months and hbv dna undetectable. key exclusion criteria: * known co-infection with hiv, hepatitis c virus, and hepatitis d virus. * receiving or planning to receive systemic immunosuppressive medications during the study or ≤2 months prior to the first dose of study treatment. * receiving or planning to receive interferon during the study or ≤12 months prior to the first dose of study treatment. * significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia. * clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤12 months prior to the screening visit. * any known pre-existing medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings.
investigating stimulation parameter and electrode mode changes on speech perception in experienced adult cochlear implant recipients

Conditions: Hearing Loss, Sensorineural

Summary: this study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.


Eligibility criteria:
inclusion criteria: * implanted with the ci600 series (ci612, ci632, ci622, ci624), ci500 series (ci512, ci513, ci532, ci522) or freedom series (ci24re(ca), ci24re(st), ci24re(cs), ci422) * at least three months after activation of the cochlear implant. * eighteen years or older at the time of consent. * user of 900hz ace (advanced combination encoder) strategy map. * score of 20% or more for cnc words presented at 60dbspl with ci alone in the test ear. * fluent speaker in english. * willing and able to provide written informed consent. exclusion criteria: * one or more electrodes turned off in the map used regularly. * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. * current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation).

Keywords: cochlear implant sensorineural hearing loss programming speech perception
to determine how effective duloxetine is in treating women 65 years and older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms

Conditions: Urinary Incontinence, Stress

Summary: the purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.


Eligibility criteria:
inclusion criteria: * female outpatient greater than or equal to 65 years of age * have symptoms of sui or stress-predominant mui for at least 3 consecutive months * have at least 7 incontinence episodes per week. for patients with mui, at least 50% of the ief must be due to stress. * is ambulatory and able to use a toilet independently and without difficulty exclusion criteria: * at visit 1 have a positive urine culture or a history of four or more urinary tract infections (utis) in the preceding year * have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry * began pelvic floor muscle exercises (for example, kegel or biofeedback) within 3 months prior to study entry or at any time during the study. * have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract. * intake of monoamine oxidase inhibitors (maois) within 14 days prior to randomisation or at any time during the study
a study to compare three existing starting points of anti-retroviral therapy (art) initiation in hiv/tuberculosis (tb) co-infected patients

Conditions: HIV Infections; Tuberculosis

Summary: this is a randomized, open-label study comparing three existing treatment strategies of art initiation in hiv/tb co-infected patients: group 1: early initiation of art with tb treatment, group 2: initiation of art upon completion of the intensive phase of tb treatment, group 3: initiation of art upon completion of the continuation phase of tb treatment approximately 700 men and women ≥ 18 years of age with documented hiv infection and smear-positive pulmonary tb patients will be enrolled. eligible tb/hiv co-infected patients will be offered antiretroviral therapy (art), starting at one of the three time points listed above through the caprisa aids treatment programme which includes extensive counselling and adherence support. the study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (art) in patients on tuberculosis (tb) treatment by comparing clinical status (cd4+ cell count, viral load, opportunistic infections.


Eligibility criteria:
inclusion criteria: * hiv infected patients co-infected with tb * receiving any one of the standard anti-tb therapy regimens * all patients must agree to use contraception since they will be on efavirenz. exclusion criteria: * entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded

Keywords: antiretroviral therapy hiv opportunistic infections cd4 viral load tb/hiv co infection treatment naive